Performs key operational activities across the Clinical Documentation Center for master files through life cycle. Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files; may be aligned by Therapeutic Area but expected to work across all areas of the organization.
location: Telecommute
job type: Contract
salary: $26 - 30 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Applies critical thinking to ensure real-time inspection readiness of clinical documentation by: - investigates and proactively resolved issues - runs and performs review of reports and dashboards within eTMF - produces eTMF metrics - communicates to Master File owner(s) root cause analysis and potential data integrity concerns
- Leads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M, DSS, BSO).
- For CRO managed study TMFs: conduct QC of artifacts (may also include uploading and classifying); involvement with transfer of CRO TMFs into eTMF system
- Provides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files): - conduct data integrity checks - run & analyze reports for TMF completeness - work with the assigned CDA to follow-up on outstanding items with other functional areas - contribute to completion of pre-inspection requests
- During an inspection: - function at the subject matter expert of the eTMF system navigation, including being present in the front room with the Auditors/Inspectors - participate in responding to auditor/inspector requests (may be required to put the response together)
- Conduct TMF conversion activities; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).
- Review regulatory documents / packages for approval of Investigational Product (IP) release and work with Artifact Owner(s) to correct errors. Provide approval for release of IP to investigator sites.
- Provides suggestions for CDC work instructions/job aides and contributes to functional area continuous improvement projects and/or work streams.
- Complies with GCP, SOPs and functional area processes.
qualifications:
Qualifications
- Bachelor's Degree
- Minimum 4 years relevant industry experience in clinical document management or equivalent experience required. If no BS, a total of 6 years professional clinical research relevant work experience.
- Proficient knowledge of clinical documentation business procedures and compliant to clinical documentation processes, identify gaps and propose solutions.
- Capable of working autonomously with limited oversight.
- Proven oral and written communication skills; ability to facilitate cross-functional team meetings.
skills: SOP, GCP (Good Clinical Practice), Trial Master File (TMF), Electronic Trial Master File (eTMF)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
